Characteristics of Diabetic Foot Ulcer Patients | NCT07188337

Studies
Characteristics of Diabetic Foot Ulcer Patients

NCT07188337

Sponsor

Golestan University of Medical sciences

Status

Recruiting

Last Update Posted

Sep 23, 2025Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Diabetic Foot Ulcer
Diabetes Complications

Interventions

Not provided

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 27, 2025Actual

Primary Completion Date

Oct 2025Estimated

Completion Date

Nov 2025Estimated

First Submitted Date

Aug 31, 2025

First Submission Date that Met QC Criteria

Sep 20, 2025

First Posted Date

Sep 23, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2025

Last Update Posted Date

Sep 23, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Pezhman Kharazm, MD, Assistant Professor of Vascular Surgery, Golestan University of Medical Sciences, Golestan University of Medical sciencesPrincipal Investigator

Lead Sponsor

Golestan University of Medical sciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study examines the demographic, clinical, and laboratory characteristics of patients with diabetic foot ulcers admitted to 5 Azar Hospital, Gorgan, in 2024. By analyzing factors such as Hb, WBC, HbA1C, ESR, and CRP in relation to ulcer severity, the study aims to identify predictors of outcomes and support more effective prevention and management strategies

Detailed Description

Diabetic foot ulcer (DFU) is one of the most serious and preventable complications in diabetic patients, often leading to infection, hospitalization, lower limb amputation, and increased mortality. This cross-sectional descriptive-analytical study aims to investigate the demographic, clinical, and laboratory characteristics of approximately 200 patients with DFU admitted to 5 Azar Hospital, Gorgan, in 2024. Data will be retrospectively collected from medical records after obtaining ethical approval.

The study will analyze relationships between patient demographics, clinical features, and laboratory findings (including Hb, WBC, HbA1C, ESR, CRP) with ulcer severity based on Wagner's classification. Statistical tests such as independent t-test, chi-square, Fisher's exact test, and multivariable logistic regression will be used.

By identifying key factors associated with ulcer severity and outcomes, the findings of this study may contribute to more effective prevention and management strategies for diabetic foot ulcers, ultimately reducing complications and healthcare costs

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Severity of diabetic foot ulcer (measured by Wagner classification at admission)	Measured by Wagner classification	Baseline
Laboratory parameters and ulcer grade	Association between Hb, WBC, HbA1C, ESR, and CRP levels with Wagner ulcer grade	Baseline

Secondary Outcomes

Measure	Description	Time Frame
Duration of diabetes until ulcer onset	Time (in years) between diabetes diagnosis and first DFU occurrence	Baseline
Smoking status and ulcer severity	Correlation between smoking history (yes/no) and Wagner ulcer grade

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients admitted to 5 Azar Hospital, Gorgan, in 2024
Diagnosis of diabetic foot ulcer (DFU) confirmed by medical records
Complete demographic, clinical, and laboratory data available in medical files

Exclusion Criteria:

Incomplete or missing medical records
Patients with foot ulcers of non-diabetic etiology
Patients whose key laboratory data are unavailable

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

The study population will consist of approximately 200 patients with diabetic foot ulcers admitted to 5 Azar Hospital, Gorgan, during 2024. Patients will be identified retrospectively from hospital medical records. Both demographic and clinical data, as well as laboratory findings, will be extracted for analysis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Pezhman Kharazm	Contact	09111751861		pezhmankh@goums.ac.ir

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
5Th Azar Medical Center	Recruiting	Gorgan	Outside of the US	4917956808	Iran

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017719	Diabetic Foot
D048909	Diabetes Complications
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D003925	Diabetic Angiopathies
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D016523	Foot Ulcer

Browse Leaves

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Browse Branches

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